MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74123148

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Infiltration into Tissue (1931); Pain (1994); Toxicity (2333); Hip Fracture (2349); Limited Mobility Of The Implanted Joint (2671); Neuralgia (4413); Metal Related Pathology (4530)

Event Date 03/01/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patients right hip on (b)(6) 2019 due to pain, limited mobility, metallosis, adverse local tissue reaction and elevated metal ion levels.The patient outcome is unknown.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision the bhr head and cup were removed.As of today, the implanted devices, all of which were used in treatment and additional information has been requested for this complaint but has not become available.A review of the complaint history for the bhr cup and bhr head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the bhr head.Similar complaints have been identified for the bhr cup.This will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as a result of the reported event.The available medical documents were reviewed.The clinical information provided in the operative report, does not appear to support the signs and symptoms usually seen with a reaction to metal debris.It cannot be concluded that the reported clinical findings are associated with the implant failure.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventive or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision the bhr head and cup were removed.As of today, the implanted devices, all of which were used in treatment and additional information has been requested for this complaint but has not become available.A review of the complaint history for the bhr cup and bhr head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the bhr head.Similar complaints have been identified for the bhr cup.This will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as a result of the reported event.The available medical documents were reviewed.The reported pain, limited mobility, elevated metal ions, intraoperative findings of synovitis, and histopathological findings of material consistent with tribocorrosion metallic debris or hemosiderin, lymphocytic infiltrate, and focal giant cell reaction associated with particle laden macrophages may be consistent with trunnionosis but also indicate inflammatory reaction to cement particles.It is noted that the revision report did note that there was no ¿frank metallosis¿ the root cause of the reported events/clinical reactions cannot be confirmed.It cannot be concluded that the reported clinical findings are associated with a mal-performance of the implant or implant failure.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive and neither a definitive nor potential root cause can be determined.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: FEMORAL HEAD 48MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 10767865
• MDR Text Key: 214099051
• Report Number: 3005975929-2020-00410
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552426
• UDI-Public: 03596010552426
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2013
• Device Model Number: 74123148
• Device Catalogue Number: 74123148
• Device Lot Number: 08LW20058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention